Other safety alerts
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| Singapore: Lemtrada (alemtuzumab): Revised indications, additional contraindications and risk minimisation measures |
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The Health Sciences Authority (HSA) announces that Sanofi-aventis Singapore Pte Ltd informs healthcare professionals of the revised indications, additional contraindications and risk minimisation measures for the use of Lemtrada (alemtuzumab).
These changes follow new safety information identified from the post-marketing use of Lemtrada and a recent assessment of its benefit-risk profile. The new safety information include reports of myocardial ischaemia, myocardial infarction, haemophagocytic lymphohistiocytosis (HLH), autoimmune hepatitis, acquired haemophilia A, Epstein-Barr virus (EBV) reactivation, haemorrhagic stroke, dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage and thrombocytopenia. Following a review of the benefit-risk profile of Lemtrada, additional risk minimisation measures will be introduced with respect to the initiation and administration of Lemtrada, infusion instructions to reduce serious reactions temporally associated with Lemtrada infusion and post-infusion monitoring advice.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/lemtrada-(alemtuzumab)-revised-indications-additional-contraindications-and-risk-minimisation-measures
In Hong Kong, Lemtrada Concentrate For Solution For Infusion 12mg/1.2ml (HK-64543) is a registered pharmaceutical product containing alemtuzumab. The product is registered by Sanofi-Aventis Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to alemtuzumab, but these cases are not related to autoimmune hepatitis, haemophagocytic lymphohistiocytosis, acquired haemophilia A or serious cardiovascular reactions.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 30 Nov 2018, with the latest update posted on 13 Feb 2020. Letters to inform local healthcare professionals were issued by the DH on 30 Nov 2018 and 15 Apr 2019.
In Sep 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack or package insert of the product should include safety information about immune-mediated conditions and problems with the heart and blood vessels. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Thursday, Jul 16, 2020
Issued at HKT 15:00
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